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Checkmate Pharmaceuticals Presents Clinical Trial Biomarker Data with Vidutolimod at the 2022 American Association for Cancer Research (AACR) Annual Meeting

·6 min read
Checkmate Pharmaceuticals Inc.
Checkmate Pharmaceuticals Inc.

CAMBRIDGE, Mass., April 08, 2022 (GLOBE NEWSWIRE) -- Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) (“Checkmate”), a clinical stage biotechnology company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, today announced the presentation of biomarker signature data from two studies evaluating vidutolimod, a first-in-class, immunostimulatory, noninfectious virus-like particle (VLP) containing a CpG-A Toll-like receptor 9 (TLR9) agonist. The first study evaluated vidutolimod in patients with advanced anti-PD-(L)1 refractory melanoma who received intratumoral vidutolimod monotherapy or in combination with intravenous pembrolizumab, and the second evaluated patients with anti-PD-(L)1 refractory non-small cell lung cancer (NSCLC) who received vidutolimod and atezolizumab. The objective of these analyses was to identify transcriptional signatures specific to the antitumor activity of treatment with vidutolimod monotherapy or in combination with PD-1 blockade in these two subsets.

Novel transcriptional signatures associated with antitumor activity in vidutolimod (vidu)-treated patients (pts) with anti-PD-1-refractory melanoma and non-small cell lung cancer (NSCLC) (Abstract #: LB107: NCT03084640 and NCT03438318)

During the 2022 AACR Late-Breaking Research: Clinical Research 2 Poster Session on Tuesday, April 12 from 9:00am - 12:30pm CT, Art Krieg, M.D., Founder and Chief Scientific Officer of Checkmate, presents analyses of RNA Seq data from baseline biopsies of tumors in patients with anti-PD-1-refractory melanoma and NSCLC.

Key highlights from these clinical trial biomarker data include:

  • Expression of a 35-gene COPII/Golgi core signature was associated with antitumor activity of intratumoral vidutolimod ± intravenous anti–PD-(L)1. This finding is consistent with published reports that COPII vesicle and Golgi trafficking are critical for TLR9 trafficking and function

  • Association with response to vidutolimod monotherapy suggests that the COPII/Golgi core signature is linked to effective TLR9 agonism. The signature was independent of tumor inflammation and baseline patient characteristics such as LDH, presence of liver metastases, or tumor burden

  • Machine learning of the RNA Seq dataset revealed that the COPII/Golgi signature in combination with ELF2 expression provided a stronger differentiation between responders and non-responders to vidutolimod, regardless of baseline tumor inflammation

  • A macrophage signature was associated with nonresponse in T cell–inflamed melanoma, consistent with other evidence that high concentrations of tumor-associated macrophages (or myeloid-derived suppressor cells) may suppress TLR9 activation by vidutolimod

  • The presence of these signatures and potential association with clinical response is being evaluated in further RNA Seq datasets being generated from ongoing clinical trials of vidutolimod in combination with various checkpoint inhibitors

“These data suggest that the tumor regression we have seen in patients treated with intratumoral vidutolimod with or without checkpoint inhibitors may be predicted from the presence of one or more novel transcriptional signatures in the baseline tumor biopsies,” said Dr. Art Krieg, Founder and Chief Scientific Officer of Checkmate. “These signatures are consistent with what we know about TLR9 biology and they provide clues to possible new combinations and patient populations who may be especially amenable to vidutolimod treatment. We look forward to determining the prevalence of these signatures in other cancers and to exploring the potential for a biomarker-based enrichment strategy across cancer.”

About Checkmate Pharmaceuticals

Checkmate Pharmaceuticals is a clinical stage biotechnology company focused on developing its proprietary technology to harness the power of the immune system to combat cancer. Checkmate Pharmaceuticals’ product candidate, vidutolimod (CMP-001), is an advanced generation Toll-like receptor 9 (TLR9) agonist, delivered as a biologic virus-like particle utilizing a CpG-A oligodeoxynucleotide as a key component, designed to trigger the body’s innate immune system to attack tumors in combination with other therapies. Information regarding Checkmate Pharmaceuticals is available at www.checkmatepharma.com.

Availability of Other Information About Checkmate Pharmaceuticals

Investors and others should note that we communicate with our investors and the public using our website (www.checkmatepharma.com) and our investor relations website (ir.checkmatepharma.com), including but not limited to: investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Checkmate Pharmaceuticals posts on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. These statements include those regarding vidutolimod (CMP-001), including its development, efficacy and therapeutic potential and the advancement of our clinical and preclinical pipeline, the ability to expand into new cancer indications, the timing of potential data read outs on our ongoing clinical trials, our anticipated cash runway, and our ability to raise additional capital to fund our clinical development program and continue as a going concern. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. These forward-looking statements are subject to risks and uncertainties, including those related to the development of vidutolimod, including any delays in our ongoing or planned preclinical or clinical trials, the results from clinical trials, including the fact that positive results from a trial may not necessarily be predictive of the results of future or ongoing clinical trials, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical supply , clinical enrollment and plans, the risks inherent in the drug development process, including related to regulatory approval, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements, the need for additional financing and the ability to obtain financing, and obtaining, maintaining and protecting our intellectual property. These and additional risks are discussed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ending December 31, 2021, as filed with the Securities and Exchange Commission which are available on the Securities and Exchange Commission’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Checkmate undertakes no duty to update this information unless required by law.

CONTACT: Investor Contact Rob Dolski Chief Financial Officer rdolski@checkmatepharma.com Media Contact Karen Sharma MacDougall Advisors 781-235-3060 ksharma@macdougall.bio